This non-significant risk study is intended to demonstrate the use of the MIRIA Skin Treatment System can show improvement in dermatologic conditions currently indicated for treatment with a laser (such as, but not limited to, benign pigmented lesions, benign cutaneous lesions, wrinkles, textural irregularities, or scars). The study is also intended to assist in determination of the optimal laser configuration and treatment parameters that most consistently yield results.
This study is intended to allow clinical evaluation of the feasibility of the MIRIA Skin Treatment System, referred to herein as the SR Skin Rejuvenation Laser, for the treatment of dermatologic conditions currently indicated for treatment with a laser (such as, but not limited to, benign pigmented lesions, benign cutaneous lesions, wrinkles, textural irregularities, or scars). This clinical evaluation is being performed under an investigational protocol to formally collect data for the treatment of different dermatologic conditions. This prospective, non-randomized, controlled study will include subjects with dermatologic conditions that are currently indicated for treatment with a laser who are willing to have sites exposed to the MIRIA Laser and who agree to comply with the study requirements during the follow-up period, a minimum of 3 months and a maximum of 18 months. Some areas with the dermatologic condition may be left as a control for the treated section. Subjects may also be directed to use some topical cream or lotion for up to 1 month prior to the laser procedure or during the duration of the study, according to the Investigator's standard practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
The MIRIA Skin Treatment System is a 1550nm-based laser system indicated for use in dermatologic procedures requiring the coagulation of soft tissue, as well as for skin resurfacing procedures.
Skinfluence Long Island
Dix Hills, New York, United States
Laser and Skin Surgery Center of New York
New York, New York, United States
Global Aesthetic Improvement Scale (GAIS)
Scale used to compare before and after images of subjects treated. Scores include the following: 1. \- Very Much Improved 2. \- Much Improved 3. \- Improved 4. \- No Change 5. \- Worse
Time frame: 3 Months
Subject Questionnaire
Questionnaire that evaluates the subjects impression of the treatment (overall discomfort score, satisfaction with treatment results, notes on treatment sensation).
Time frame: Immediate Post Treatment, 3 Months Post Treatment
Adverse Event Assessment
An assessment of side effects and adverse event profile to ensure safety of treatment. Data collected included the event, the duration, the severity, and any other interventions that may occur due to the adverse event.
Time frame: Immediate Post Treatment, 3 Months Post Treatment
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